EPE · Brush, Cleaning, Tracheal Tube
Anesthesiology · 21 CFR 868.5795 · Class 1
Overview
| Product Code | EPE |
|---|---|
| Device Name | Brush, Cleaning, Tracheal Tube |
| Regulation | 21 CFR 868.5795 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
| GMP Exempt | Yes |
Identification
A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863635 | UPDATED STERILE ENDOTRACHEAL BRUSHES | Biological & Environmental Control Laboratories | Nov 3, 1986 | SESE |
| K862563 | TRACHEOSTOMY CLEANSING SOLUTION | Clinipad Corp. | Jul 15, 1986 | SESE |
Top Applicants
- Clinipad Corp. — 1 clearance
- Biological & Environmental Control Laboratories — 1 clearance
